FDA.reportPublic FDA data

ANTIBACTERIAL HANDWASH

Manufacturer
Universal Distribution Center LLC
Effective date
2024-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:41:57

Label at a glance#

ProductANTIBACTERIAL HANDWASH CUCUMBER and TEA TREE
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Benzalkonium Chloride 0.13%

OTC - PURPOSE SECTION

Purpose

Antibacterial

INDICATIONS & USAGE SECTION

USES for hand washing to decrease bacteria on the skin.

WARNINGS SECTION

Warning: Avoid contact with eyes. In case of contact flush with water. Keep out of direct sunlight. Do not drink, not edible. External use only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions: Pump a small amount of soap into wet hands, rub hands together to create rich lather, then rinse.

INACTIVE INGREDIENT SECTION

Ingredients: Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Cocamide MIPA, Laureth-4, Glycerin*, Polyquaternium-7*, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Citric Acid, Benzophenono-4, Tocopheryl Acetate, FD&C Blue No. 1, D&C Red No. 33

*Contains one or more of these ingredients.

SPL UNCLASSIFIED SECTION

Kill Germs and Odors

Distributed By:
Universal Distribution Center
96 Distribution Boulevard,
Edison, NJ 08817

Made in Turkey

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cucumbr1cucumbr1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-048-01ANTIBACTERIAL HANDWASHCUCUMBER and TEA TREE400 mL in 1 BOTTLELIQUID4002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-048ANTIBACTERIAL HANDWASH CUCUMBER AND TEA TREE (BENZALKONIUM CHLORIDE) LIQUID [UNIVERSAL DISTRIBUTION CENTER LLC]2Current NDC, Legacy NDC, 1 package rows20241212_585ee68f-14fc-4b1f-b078-d31251bbc3f3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52000-04852000-048-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
SODIUM CHLORIDE451W47IQ8XIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO MONOISOPROPANOLAMIDE21X4Y0VTB1IACT
LAURETH-46HQ855798JIACT
GLYCERINPDC6A3C0OXIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
EDETATE SODIUMMP1J8420LUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SULISOBENZONE1W6L629B4KIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTIBACTERIAL HANDWASH CUCUMBER and TEA TREEBENZALKONIUM CHLORIDEUniversal Distribution Center LLC585ee68f-14fc-4b1f-b078-d31251bbc3f32024-12-06WarningsExact identifier
ndc (package): 52000-048-01
ndc (product): 52000-048
ndc11 (package): 52000004801
spl id: e1dded81-9b2c-44e5-a535-4d60e6c2ecbd
spl set id: 585ee68f-14fc-4b1f-b078-d31251bbc3f3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.